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Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration

NCT05643118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-12-11

No results posted yet for this study

Summary

This is a Phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, and Part B is a multiple ascending dose study. The primary objective is to evaluate the safety and tolerability of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD. The exploratory objectives are to evaluate the preliminary efficacy of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD, and to evaluate the pharmacokinetics (PK) of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

GENETIC

OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)

Clear colorless solution dissolved in 1X PBS and injected intravitreally

Sponsors & Collaborators

  • Trial Runners, LLC

    collaborator OTHER

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • Olix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Toni Bransford, MD · Olix Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2024-11-25
Completion
2025-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643118 on ClinicalTrials.gov